On April 21, the official website of the Drug Evaluation Center (CDE) of the State Food and Drug Administration of the People's Republic of China (CFDA) recently announced that Ganli Pharmaceutical's Class 1 new drug, GZR102, has obtained the implied license for clinical trials in China and plans to develop and treat type 2 diabetes. According to the announcement of Ganli Pharmaceutical, GZR102 injection is a fixed ratio compound weekly preparation of basic insulin and glucagon like peptide-1 receptor agonist (GLP-1 RA) independently developed by Ganli Pharmaceutical. It is composed of GZR4 injection of under development ultra long acting insulin and GZR18 injection of ultra long acting GLP-1 RA bovaglutide in a fixed ratio. This is the first time that the product has been approved for clinical use in China.

Both GZR4 and Bofanglutide have fully explored the drug dosage in the phase II clinical trial carried out in patients with type 2 diabetes. On the basis of good safety and tolerance, the two drugs show excellent hypoglycemic efficacy. At present, the global development of unilateral GZR4 and bovaglutide has entered the phase 3 clinical research stage.

According to public information from Ganli Pharmaceutical, GZR4 is an innovative insulin weekly formulation developed by modifying human insulin molecules. After subcutaneous injection, GZR4 can firmly and reversibly bind with albumin, forming a "circulating storage reservoir", which allows the candidate drug to continuously and stably release insulin, thereby meeting the patient's basal insulin needs for a whole week. This product will enter Phase III clinical research in February 2025, and will be used to treat diabetes.

Bofanglutide injection is a kind of GLP-1RA administered once every two weeks to treat adult type 2 diabetes and weight management of obese/overweight individuals. Currently conducting Phase 3 clinical trials in China and Phase 2 clinical trials in the United States with indications for obesity/overweight. The previously announced results of phase 1b/2a clinical trials showed that after 35 weeks of treatment, this innovative GLP-1 receptor agonist reduced weight in obese subjects by 18.6% (placebo adjusted).

Compared with single component, GZR102 is expected to better reduce glycated hemoglobin (HbA1c), have better weight control advantages compared to basal insulin, and is expected to reduce the risk of hypoglycemia. At the same time, the currently available fixed ratio combination of basal insulin/GLP-1RA is a daily formulation, and patients need to inject it daily. GZR102 injection is expected to reduce the injection frequency, further improve the medication compliance of patients and improve the quality of life of patients with type 2 diabetes while achieving good safety and effectiveness.